The invention relates to the use of the internet in medical and clinical research.
The conduct of trials for a new drug, food supplement or other human or animal intended preparation is typically done through clinical trials. Conventionally, clinical trial participants are monitored at one or more central site(s), such as a doctor's office, clinic, hospital, or other health care facility. The participants are either institutionalized at or must make regular visits to such a facility to be checked, to receive new medications, or to otherwise consult with the trial's principal investigators and their assistants. The trials typically involve more than one substance being administered: at least one being a test substance—i.e., a compound or preparation having a hoped-for effectiveness—and at least one being a placebo or control substance. Multiple test substances of expected effectiveness are often used.
The requirement for regular appearance of participants at a monitoring facility has a number of disadvantages, particularly for trials for interventional drugs. These disadvantages include the burden on the researchers and/or their assistants to spend time scheduling visits, to conduct interviews with each participant, and to compile data on the effectiveness of each substance undergoing test. This burden is magnified by the number of substances and placebos involved in the trial. The need for a large number of participants for statistical accuracy further increases the burden, both in terms of time and resources. Conventional trials having many participants also usually involve multiple test facilities, and staff and resources at each facility in order to conduct the trial there.
Moreover, the scheduling of participant visits is based on information and other factors that are not necessarily interactive with the participant, and thus visits may be at inappropriate or inconvenient times. This can lead to inadequate participant monitoring and/or to non-compliance with a trial protocol, which may adversely affect the accuracy of clinical trial results.
Because of the time burden on the research staff and the ineffectiveness of the timing of visits or data acquisition from the participants, it is nearly impossible to test a large number of drugs in a single, conventionally conducted trial in order to have a more effective way of drug comparison.
The need for the participants to travel to the monitoring facility is also a burden on their time and produces results that can be biased by having data collected in other than a relaxed, customary or home setting. This travel also prevents the data being given and taken in real time or close to the actual time of the participant's observations that are the basis of the data gathered in the trial. Such a time lag can also affect the accuracy of the information gathered and bias the trial results.
The present invention addresses the preceding problems of conventional clinical trials, through a heretofore unexplored medical application of the internet. The invention encompasses conducting major, even all, aspects of a clinical trial on-line, including direct monitoring or evaluation of trial participants. Because of the vast scope of the internet, it may be possible to study the attributes of a wide variety of compounds, including ones that are difficult or impractical to evaluate in traditional clinical trial formats, which typically use clinic-based settings, often at multiple clinics. For example, there exist a number of nutritional compounds or food supplements (commonly called “nutriceuticals”) that may be modestly effective in relieving symptoms of a non-life-threatening condition. Because of the large numbers of participants required and of the prohibitive costs involved in detecting efficacy from these compounds, it is unlikely that they will all be adequately evaluated by traditional, clinic-based trials. On the other hand, the internet, through use of validated symptom-monitoring questionnaires, can have great utility in facilitating the effective and economical testing of non-toxic, safe compounds in the treatment of various conditions, e.g., osteoarthritis.
Some publications have explored the potential of the internet for facilitating purely observational, epidemiological studies and describe how recent software developments can be used to enhance data security, allow automated data compilation and evaluate in-coming data in real-time. i,ii,iii The internet has also been proposed as a vehicle for facilitating the conduct of large, multi-center, conventional clinical trials by allowing global access to collected data, fast interaction with the database and automation of some aspects of data collection and manipulationiv. However, until the present invention, there has been no suggestion to use the internet to direct and monitor, from a central site, the administration of an interventional test substance to trial participants at remote sites.